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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Study performed according to internal company standards (BASF-test) before actual guideline was adopted.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: unspecified amount
- Concentration: 100 % (undiluted)
Duration of treatment / exposure:
1, 5, 15 min and 20 hours (ear: only 20 hours)
Observation period:
24, 48, 72 hours, 6 days and 8 days after beginning of application (exception: application time 20 hours: no observations after 24 hours)
Number of animals:
2 (1, 5 and 15 min); 2 (20 hours)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm area of skin on the back and the ear
- % coverage: not specified (application site 2.5 x 2.5 cm)
- Type of wrap if used: cotton pad soaked with the undiluted test substance, covered by an impervious bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water, sometimes containing a mild detergent
- Time after start of exposure: 1, 5, 15 min, 20 hours (after the application)

SCORING SYSTEM: BASF scoring system, convertible to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritant / corrosive response data:
After 1, 5, 15 min of exposure, no signs of irritation (erythemy, edema) were apparent after 24, 48 and 72 hours and after 6 and 8 days. After 20 hours of exposure no signs of irritation (erythema, edema) were apparent after 48 and 72 hours and after 6 and 8 days
Other effects:
No mortality occurred. There were no clinical signs of systemic toxicity from the dermal exposure.

Any other information on results incl. tables

No individual animal scores given in the report

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information